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| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 24/02/2025 | ACS DOBFAR SPA |
Italy |
ACS DOBFAR SPA | 13762 | AMIKACIN BASE | 1998-09-01 | Active | II | N/A | ||
| 24/02/2025 | Bristol Myers Squibb |
U.S.A |
BRISTOL MYERS SQUIBB CO | 13527 | AMIKACIN BASE | 1998-09-01 | Inactive | II | N/A |
